NIHR Research Design Service London

Professor Azeem MajeedDepartment of Primary Care & Public Health

Research Design Service (RDS)

A national network of support services;

REGIONAL RDSNorth EastNorth WestYorkshire and the HumberWest MidlandsEast MidlandsEast of EnglandSouth WestSouth CentralLondonSouth East

Supporting those who are putting together

research grant applications for national peer-

reviewed funding streams

RDS London

Imperial College London

Queen Mary University London

University College London

King’s College London

A successful partnership

We provide free design and methodological support to health and social care researchers who are developing applications to NIHR and other national, peer-reviewed funding programmes.

Access RDS London support:

Complete our online support request form to request individual advice or a consultation

Visit our drop in sessions around London to discuss emerging ideas for research with our advisors

Guidance and resources on our website

Attend our events and seminars

Research Design Service London

Professor Azeem Majeed (Primary Care and Public Health)

Dr Victoria Cornelius (Imperial Clinical Trials Unit)

Dr Laura Vanderbloemen (Senior Research Adviser)

Ms Hilary Watt (Statistician)

Dr Roger Newson (Statistician)

Dr Shikta Das (Statistician)

Dr John Lee (Economist)

Ms Kimberley Foley (Research Adviser)

Your Local RDS Team

Our expertise

Local RDS centres: Teams of advisers with a wide range of methodological expertise

o Statistician

o Health economist

o Social scientist

o Health psychologist

o Epidemiologist

o trial design

o qualitative research methods

o Patient Public Involvement

Our aim

“Increase the volume and proportion

of high quality research grant

applications”

Our role

Provide project specific guidance

and expertise on study design

and health research methods.

Free of charge

Much more than research design…

Help identify most suitable funding stream

Our support

Support teams in working more collaboratively

Advise on patient and public involvement

Help get the narrative right

Advise on training and development plans

Interview preparation / mock interviews

Help interpret feedback, support resubmissions

Who can we help?

Those with little experience of research

Those targeting a resubmission

Applicants with experience of submitting funding applications

Clinicians eager to exploit ideas or observations

Fellowship applicants

Those requiring advice on study design

Access to the service

Online:

Through our website

Simple online support request form

Greater range of online resources

www.rds-london.nihr.ac.uk

Access to the serviceOutreach:

Regular ‘drop-in’ sessions

across London

Events / clinics aligned with NIHR funding calls

Supporting local NHS Trust R&D events

Presentations to therapeutic communities and

research groups

Delivering the service

‘Primary care’

Initial review

feedback

Focuses on the ‘big’ questions,

PPI. All important

triage step

‘Secondary care’

Specialist input

Sample size, methods for

economic evaluation, mixed

methods approaches etc

‘Tertiary care’

Facilitating additional support

Links with Trust R&D, CTUs and

other established research networks

Online resources

Researchers guides. LinksRDS insights,

checklists, tips

‘Self care’

Adding value

NIHR SAF feedback

99% of researchers would recommend using RDS

98% say we improve the quality of their applications

97% are satisfied with the service

A record of achievement

Between July 2009 and July 2016:

431 successful RDS London supported studies;

total award value in excess of £170m

When should I contact RDS?

As early as possible

Ideally at least 3 months

ahead of submission deadline

Need 2-3 months for really

good input

Sources of funding for research

Sources of funding

MRC (approx £500m per annum)

Tends towards ‘basic’ or ‘discovery’ research

Wellcome Trust (approx £500m per annum)

Mainly biomedical, also medical history and humanities

Medical charities (approx £500m per annum)

Mainly disease-based

ESRC (approx £200m per annum)

Social science projects

Not interested in projects with too much ‘health’ in them

NIHR (approx £1 billion per annum)

Funds programmes, projects, fellowships

www.nihr.ac.uk/publications/

NIHR funding for research

Information about NIHR’s research funding and career development opportunities

Basic research, preclinical studies & proof of concept

Phase II: early evidence of clinical efficacy

Single centre trials located regionally

Phase III/IV: multicentre trial; clinical & cost effectiveness of intervention

Health Technology Assessment (HTA)

Evidence on quality, accessibility & organisation of health services

Evaluation of public health interventions (non-NHS)

Translational development of technologies with potential for commercialisation (may have industry partners)

Efficacy & Mechanism Evaluation (EME)

Invention for Innovation (i4i)

Programme Grants for Applied Research (PGfAR)Also Programme Development Grants (PDG)

Public Health Research (PHR)

A simplified outline of NIHR funding programmesInvention

Teams of leading researchers with an interrelated group of high quality projects focused on a coherent theme (PDG is preparatory work for PGfAR)

Medical Research Council

Evaluation

Research for Patient Benefit (RfPB)

Therapies, tests, procedures, screening, devices, drugs, interventions, etc.

Health Services & Delivery Research (HS&DR)

Adoption

Contact the NIHR co-ordinating centre for your programme:

Central Commissioning Facility (CCF)

o Research for Patient Benefit (RfPB), Programme Grants (PGfAR and PDG), Invention for Innovation (i4i)

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)

o Health Technology Assessment (HTA), Efficacy and Mechanism Evaluation (EME), Health Services and Delivery Research (HS&DR), Public Health Research (PHR)

Trainees Co-ordinating Centre (TCC)

o Fellowship schemes

NIHR funding programmes

General Points:

Applications submitted on a Standard Application Form (SAF)

NIHR funding programmes

Outline and Full applications for most NIHR funding streams.

Fellowship schemes are single stage.

Multiple calls for proposals each year

Researcher-led, commissioned and themed calls Independent peer review, then assessment by funding committee

Feedback is given, no lobbying but resubmissions are allowed

Eligibility rules vary for NHS / HEI applicants

Efficacy and Mechanism Evaluation (EME) Overview:

Bridge the gap between preclinical study and evidence of clinical efficacy

Proof of concept in humans – starting point

Supports early phase trials in an ideal setting

Outcome – clinical efficacy. Surrogates OK.

Mechanistic studies encouraged, but optional

Remit includes evaluation of small molecules, biologics, psychological interventions, diagnostics, medical devices

Treatments to prevent disease are also included

Collaborative working between NHS, academia and Industry (2/3)

FUNDING DEADLINES - Researcher led: 15 March 2016 July 2016 Nov 2016

Efficacy and Mechanism Evaluation (EME)Example:

Phase II randomised controlled trial to determine the efficacy of an IL-1 receptor antagonist to treat those with pustular psoriasis compared with placebo

Proof of Concept – 7 patients with pustular psoriasis showed complete resolution with IL-1RA

Studying efficacy (n=64 in each arm of the trial) of a re-purposed intervention (IL-1RA)

Exploring a novel scientific principle that IL-1 over-production is treatable

Using mechanistic studies to determine whether gene mutations are associated with treatment outcome

Research for Patient Benefit (RfPB)Overview:

Funds projects that are regionally focused (unique feature)

Funds projects into everyday practice that address issues of importance to the NHS

Trajectory to patient benefit needs to be explicit

£350K limit - research with clear, close trajectory to patient benefit

£250K limit for feasibility studies (for a future clinical trial)

£150K limit for ‘higher risk’ developmental / exploratory studies

Good option for investigators looking for their first grant

FUNDING DEADLINES - Researcher led: 23 March 2016 July 2016 Nov 2016

Research for Patient Benefit (RfPB)

Example:

Single blind randomised controlled trial using hot water bottle to

provide evidence that local heat pre-conditioning can reduce skin necrosis

and to assess the feasibility (recruitment, retention, incidence of necrosis)

of undertaking a large multicentre trial.

Health Technology Assessment (HTA)Overview:

Evaluates a wide range of ‘technologies’ delivered within NHS

‘Technology’ needs to be fully developed and defined

Often a pragmatic multi centred RCT

Supports projects that study effectiveness / cost effectiveness

Outcomes need to measure health gain and matter to patients

Remit includes interventions to promote health, prevent or treat disease, improve rehab or long term care. Includes drugs, devices, procedures, settings of care and screening.

FUNDING DEADLINES - Researcher led: 8 April 2016 10 Aug 2016 30 Nov 2016

Health Technology Assessment (HTA)Example:

A phase III randomised controlled trial of the effectiveness of anti-inflammatory treatment on eye surgery in those with open globe trauma, compared to standard treatment

The study built upon two pilot studies that demonstrated clinical efficacy and feasibility of a large scale trial

Multicentre study (20 specialist eye units, typical of NHS care of ocular trauma), n = 302, duration = 4 years

Primary outcome = capacity for eye to see fine detail at 6 months

Cost effectiveness analysis

Public Health Research (PHR)Overview:

Focuses on evaluating effectiveness / cost effectiveness of public health interventions that are outside of the NHS (complements HTA)

Evaluation of non NHS interventions intended to improve the health of the public, prevent disease and reduce inequalities.

Example:

A randomised controlled trial and economic evaluation of a community-based physical activity intervention to prevent mobility-related disability for retired older people.

FUNDING DEADLINES - Researcher led: 4 April 2016 Aug 2016 Dec 2016

Basic research, preclinical studies & proof of concept

Phase II: early evidence of clinical efficacy

Single centre trials located regionally

Phase III/IV: multicentre trial; clinical & cost effectiveness of intervention

Health Technology Assessment (HTA)

Evidence on quality, accessibility & organisation of health services

Evaluation of public health interventions (non-NHS)

Translational development of technologies with potential for commercialisation (may have industry partners)

Efficacy & Mechanism Evaluation (EME)

Invention for Innovation (i4i)

Programme Grants for Applied Research (PGfAR)Also Programme Development Grants (PDG)

Public Health Research (PHR)

A simplified outline of NIHR funding programmesInvention

Teams of leading researchers with an interrelated group of high quality projects focused on a coherent theme (PDG is preparatory work for PGfAR)

Medical Research Council

Evaluation

Research for Patient Benefit (RfPB)

Therapies, tests, procedures, screening, devices, drugs, interventions, etc.

Health Services & Delivery Research (HS&DR)

Adoption

Health Services and Delivery Research (HS&DR)

Overview:

Funds research to produce evidence on the quality, accessibility and organisation of health services. This includes evaluations on how the NHS might improve the delivery of services, research on implementation and knowledge mobilisation

Example:

Reorganising specialist cancer surgery: a mixed methods evaluation. What is the impact of centralising specialist cancer surgery on provision of care? What is the impact on patient experience, choice and continuity of care? What is the impact on ways of (staff) working?

FUNDING DEADLINES - Researcher led: 14th Apr 2016 Aug 2016 Dec 2016

Invention for innovation (i4i)Overview:

Supports research and development of innovative healthcare technologies, which have potential for commercialisation and acceptance within the NHS (e.g. medical devices, implantable devices and in vitro diagnostics)

Supports projects through prototype and commercial development to introduction and adoption in the NHS

Supports projects that develop technologies from other sectors that could have an impact in healthcare

Example: Novel zinc bioglass coatings to eliminate infections associated with orthopaedic wires and pins. Testing the feasibility of using biodegradable zinc glasses to reduce infections.

FUNDING DEADLINES - Researcher led: 13 Jan 2016 May 2016 Sept 2016

Programme Grants for Applied Research (PGfAR)Overview:

Funds programmes of applied research (projects / workpackages linked with a clear theme and where combination gives added value)

Prestigious awards for leading researchers who can demonstrate an impressive track-record of achievement in applied health research

Funds projects that are a priority for the NHS that require a multidisciplinary approach (typical input from clinical, health economics, statistics, qualitative, health psychology backgrounds)

Target Programme Development Grant (PDG) for addressing limitations of a future PGfAR application (£20-100K over 6-18m)

FUNDING DEADLINES - Researcher led: 6 Apr 2016 27 July 2016 Dec 2016

FUNDING DEADLINES - Researcher led: 8 Mar 2016 22 July 2016 Nov 2016

NIHR Themed calls Issued to address an identified health challenge or government priority

Previous calls have focused on dementia, very rare diseases, surgery,

primary care interventions, antimicrobial resistance, long-term

conditions in children and young people, and mesothelioma.

All NIHR research programmes take part

NIHR infrastructure joins together to support the call

Not short-term initiatives, but act as pump-primers that draw

attention to national priorities and promote greater research activity

NIHR funding programmes are always interested in receiving

applications (as part of their usual researcher-led workstreams) even

after the initial promotion of the theme has ended.

Prevention and treatment of obesity Research into the evaluation of interventions or services for the

prevention and treatment of obesity in adults and children.

Issues of particular importance for this call include the prevention

of type 2 diabetes and increasing levels of physical activity.

NIHR Themed calls

FUNDING DEADLINES – EME, HTA, HS&DR, PHR, i4i, PGfAR RfPB

6th Apr 2016

23rd March 2016

NIHR commissions research that addresses specific topics/themes.

Important questions (for NHS) agreed by prioritisation panels.

Priority or gap in knowledge has already been identified by

policy/decision makers

Applications are assessed on how well they fit the commissioning

brief.

NIHR Commissioned calls

Fellowship schemesOverview:

Personal awards / institutional awards covering salary, training and development costs and research costs.

A person with potential and trajectory for their career

A good project with aims of the funder

A tailored training/development package

Suitable institution and supervision

Pre-doctoral, doctoral, post-doctoral, senior/pre-chair, chair

Advice on good writing style• Many style guides are

available• Pick one that you like• I generally recommend

“Medical Writing: A Prescription for Clarity”

• “From Creation To Chaos: Classic Writings in Science” Edited by Bernard Dixon

Some basic points about writing style

• Spend time acquiring a good, readable style of writing

• Be clear and concise• Avoid using too many long sentences• When you have the choice of two words, use

the simpler one• Use active rather than passive verbs• Avoid using colloquial language & cliches

What did Winston Churchill say?

• He said “I have nothing to offer but blood, toil, tears and sweat”

• He did not say “I have nothing to offer but the red liquid that circulates in blood vessels, exertion, lacrimation and perspiration”

• He said “We will fight them on the beaches”• He did not say “We will fight them on the

coastal perimeters”

Some examples rewritten1: In the case of this particular elderly patient hypertensive population, reduction of blood pressure by 18/11 mm Hg was achieved for a mean duration of follow up period of 4.4 years. However, with regard to overall mortality, there was no effect nor was there any effect on the incidence of occurrence of myocardial infarction, whether of fatal or non-fatal nature. With respect to cardiovascular accidents, a reduction in incidence of 42% was encountered, and this was mainly associated with strokes leading to fatality or serious neurological sequelae. Although it was not significant, cardiovascular mortality was shown to be reduced by 22%.In these elderly patients with hypertension, blood pressure decreased by 18/11 mm Hg for a mean follow up of 4.4 years. There was no effect on overall death rates or on the incidence of fatal or non-fatal heart attacks, but there were 42% fewer strokes, mainly apparent in fatal and major strokes. Deaths from cardiovascular disease decreased by 22%, but this was not statistically significant.

2: It is possible to speculate that operative intervention would have saved this man’s life. The policy of management was conservative because of uncertainty as to the cause of deterioration.An operation might have saved this man’s life, but we did not operate because we did not know why he had deteriorated.

3: Each case has to be managed individually after a full history has been taken, and examination and, where necessary, special investigations have been undertaken, so that an accurate diagnosis can be made and appropriate treatment selected.Each case has to be managed individually. A full history and examination and any necessary special investigations will enable an accurate diagnosis and appropriate treatment.

4: Baby walkers are devices that provide preambulatory infants with postural support in addition to offering them the opportunity to experience bipedal locomotion. They are intended to simulate independent walking and by so doing, it is argued, encourage and even accelerate the early acquisition of this skill.Baby walkers are devices that allow babies who are still at the crawling stage to stand and to practise walking. Some authorities believe that they speed up the ability of babies to walk independently.

Source: Medical Writing. A Prescription for Clarity

Even the best writers can be rejected

Contact Details

Email: a.majeed@imperial.ac.uk

Twitter: @Azeem_Majeed

Facebook: https://www.facebook.com/azeem.majeed

Blog: http://medical-centre.blogspot.co.uk/

Research Design Service London

www.rds-london.nihr.ac.uk

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